Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04724252
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.3
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.

We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Gabapentin; Other: Placebo	Phase 2/Phase 3

Detailed Description

This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment.

60 subjects will be randomized in a 1:1 ratio to either:

• Gabapentin treatment group

• Placebo - control group

We aim to understand the impact that gabapentin use peri and post operatively has on:

1. opioid use based of IV morphine

2. pain scores

3. opioid related complications such as withdrawal

4. effects on the level of sedation

5. Possible adverse effects associated with use of gabapentin

6. Time to extubating

The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):
• Masking: Double (Participant, Investigator)
• Masking Description: This study is a double-blind, placebo controlled, randomized study. Physician and families will be blinded to the randomization.
• Primary Purpose: Treatment
• Official Title: Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
• Actual Study Start Date: Aug 23, 2021
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gabapentin Treatment Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.	Drug: Gabapentin; Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
Placebo Comparator: Control Group Given placebo which coincides with the active treatment group	Other: Placebo; Control Arm

Outcome Measures

Primary Outcome Measures

1. Amount of pain medication needed. [7 days post-operative or until discharge, whichever came first]

   Amount of pain medication needed after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age newborn to < 18 years.

2. Gestational age to be minimum 38 weeks.

3. Undergo cardiac surgery via a sternotomy or thoracotomy.

4. Any Thoracic Surgery

5. Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).

6. Surgery will result in an inpatient stay of at least 48 hours.

Exclusion Criteria:

1. Use of opioids within 30 days prior to study entry.

2. Renal Failure as defined by RIFLE Criteria.

3. History of seizures requiring active treatment.

4. History of chronic pain treated medically.

5. Diagnosis of Autism.

6. Unable to tolerate enteral medications.

7. Hematology/Oncology patients.

8. Parents/legal guardians unable to consent.

9. Participation in another clinical study presently or within the last 30 days

10. Pregnancy

11. Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Learn more or sign up for the study here!

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04724252
• Other Study ID Numbers: 1571754
• First Posted: Jan 26, 2021
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by University of California, Davis: thoracic surgery; cardiac surgery via a sternotomy or thoracotomy
• Additional relevant MeSH terms: Pain, Postoperative; Gabapentin

Study Results

No Results Posted as of Feb 1, 2022